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510(k) K090006

LIFEBRIDGE B2T, MODEL 7001 by Lifebridge Medizintechnik AG — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2009
Date Received
January 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Lifebridge Medizintechnik AG

  • K111384 — LIFEBRIDGE (May 24, 2011)
  • K103357 — LIFEBRIDGE (December 27, 2010)

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  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)